Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

Novartis

Overview

This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Chronic Hepatitis B

Interventions

Telbivudine (LdT)DRUG

Adefovir DipivoxilDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Documented compensated chronic hepatitis B defined by clinical history compatible with compensated chronic hepatitis B * Detectable serum HBsAg at the Screening visit Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Patient is pregnant or breastfeeding. * Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV * Patient previously received lamivudine, adefovir dipivoxil, or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog at any time * Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study Other protocol-defined exclusion criteria may apply.

Locations (15)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Pasadena, California, United States

Unnamed facility

San Francisco, California, United States

Unnamed facility

Data from ClinicalTrials.gov

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